Elongate implant containing a structurally encoded pin, carrier and reading system therefor

ABSTRACT

A carrier for retaining a plurality of implants each comprising a structurally encoded pin, the structurally encoded pin having a shape or surface characteristics discernable by an imaging modality such as x-ray, fluoroscopy, computed tomography, electromagnetic radiation, ultrasound, visible light, UV light, magnetic resonance imaging, positron emission tomography and neutron imaging, from outside the carrier, the shape or surface characteristics representing structurally encoded data. The invention further discloses a carrier for viewing a plurality of implants, and associated reading systems for reading a plurality of implants. Finally, the invention discloses methods for reading a plurality of implantable devices retained within a carrier.

RELATED APPLICATION DATA

This application incorporates by reference all of the following in theirentirety: (i) U.S. Provisional Application No. 61/938,475, filed Feb.11, 2014; (ii) U.S. patent application Ser. Nos. 14/302,133, 14/302,171(now U.S. Pat. No. 9,101,321) and Ser. No. 14/302,197, all filed Jun.11, 2014; (iii) U.S. patent application Ser. No. 14/456,665, filed Aug.11, 2014; (iv) U.S. Provisional Application No. 62/035,875, filed Aug.11, 2014; (v) U.S. patent application Ser. No. 14/823,234, filed Aug.11, 2015 (now U.S. Pat. No. 9,424,503); (vi) U.S. patent applicationSer. No. 14/822,613, filed Aug. 10, 2015 (now U.S. Pat. No. 9,414,891);(vii) U.S. Provisional Application No. 62/204,233, filed Aug. 12, 2015;U.S. patent application Ser. No. 15/235,914, filed Aug. 12, 2016; (viii)U.S. Provisional Application No. 62/419,373, filed Nov. 8, 2016 andentitled Method of Producing Elongate Implant Containing A StructurallyEncoded Pin Through Electrical Discharge Machining; (ix) U.S.Provisional Application No. 62/419,341, filed Nov. 8, 2016 entitledElongate Implant Containing A Structurally Encoded Pin, Carrier AndReading System Therefor; and (x) U.S. Provisional Application No.62/419,364, filed Nov. 8, 2016 entitled Optical Image Vertebral ImplantCage and Reading System Therefor. All of the forgoing are herebyincorporated by reference in their entirety.

CROSS-REFERENCE

This application claims priority from U.S. Provisional Application Nos.62/419,364, 62/419,341, 62/419,353 and 62/419,373, all of which werefiled on Nov. 8, 2016. This application is also a continuation in partof: (i) U.S. patent application Ser. No. 14/456,665, filed on Aug. 11,2014, which claims priority to Provisional Patent Application Ser. No.61/938,475 filed on Feb. 11, 2014; (ii) U.S. patent application Ser. No.15/243,036, filed on Aug. 22, 2016, which is a continuation of U.S.patent application Ser. No. 14/823,234, filed on Aug. 11, 2015, (nowU.S. Pat. No. 9,424,503), which claims the priority benefit of U.S.Provisional Application No. 62/035,875, filed Aug. 11, 2014; and (iii)U.S. patent application Ser. No. 15/403,063, filed on Jan. 10, 2017,which is a continuation of U.S. patent application Ser. No. 15/243,036,filed Aug. 22, 2016, which is a continuation of U.S. patent applicationSer. No. 14/823,234, filed on Aug. 11, 2015, (now U.S. Pat. No.9,424,503), which claims the priority benefit of U.S. ProvisionalApplication No. 62/035,875, filed Aug. 11, 2014.

FIELD OF THE INVENTION

The present invention relates to elongate implants containing astructurally encoded pin, a carrier and reading system therefor, as wellas methods of identifying and encoding implants and systems foridentifying and encoding implanted devices.

BACKGROUND OF THE INVENTION

Medical implant devices used in surgical procedures can be associatedwith particular information to guide medical professionals before andafter the surgical procedure. Each implant device carries a wealth ofinformation that is valuable to the patient, the implant manufacturer,medical researchers, healthcare professionals, and medical facilities.However, the information, which may include without limitation theimplant manufacturer and manufacturer's lot number, the date andlocation of surgical implantation, the responsible surgeon, any medicalnotes, photographs, or diagrams relating to the implant, surgery, orcondition, may not be adequate, properly recorded, or readily accessiblefor beneficial use by a healthcare professional, implant manufacturer,or medical researcher after implantation. Problems relating to poorimplant records can lead to unnecessary delay or even medical error byhealthcare professionals. Moreover, there are many different implantidentification methods currently in place instead of a common system toallow manufacturers, distributors, and healthcare facilities andprofessionals to effectively track, identify, and manage implant devicesand medical device recalls. The U.S. Food and Drug Administrationrecently announced a program focusing on requirements for unique deviceidentifiers for every medical implant device to address the need for amore robust implant device identification system, the details of whichare incorporated by reference herein: www.fda.gov/udi as of the filingdate.

In the use of elongate implants it is also beneficial to provide meansfor organizing, reading, inventorying, and using such implants in atherapeutic application, such as in surgical settings and the like.Consequently, there is a long felt need in the art for an implant devicethat enables a provider to quickly and un-invasively retrieveinformation from said implanted device, post implantation. There is alsoa long felt need for a structurally encoded implant device, such as apin that protects patient privacy. Finally, there is a long felt needfor a structurally encoded implantable device that accomplishes all ofthe forgoing objectives, and that is relatively inexpensive tomanufacture and safe and easy to use.

SUMMARY OF THE INVENTION

The following presents a simplified summary in order to provide a basicunderstanding of some aspects of the disclosed invention. This summaryis not an extensive overview, and it is not intended to identifykey/critical elements or delineate the scope thereof. Its sole purposeis to present some concepts in a simplified form as a prelude to themore detailed description later.

In accordance with an aspect of the invention, the present inventioncomprises an elongate implant containing a structurally encoded pin,such as a functional screw bearing an encoded, longitudinally-extendingradiopaque insert. This aspect of the invention includes an elongateimplant containing a structurally encoded insert, comprising: an implantbody defining a longitudinal axis; and a structurally encoded pincontained within the implant body and aligned substantially along thelongitudinal axis, the structurally encoded pin comprising a shape orsurface characteristics discernable by an imaging modality such as, butnot limited to, x-ray, fluoroscopy, computed tomography, electromagneticradiation, ultrasound, magnetic resonance imaging, positron emissiontomography and neutron imaging modalities from outside the screw body,the shape or surface characteristics representing structurally encodeddata. The readable portion of the encoded pin may further comprise aradiopaque insert and indicia disposed along at least one surfacethereof or disposed within the implant. The indicia may comprise aplurality of modifications to at least one surface of the radiopaqueelement or a plurality of radiopaque elements disposed within thereadable portion such that the indicia are discernible by any imagingmodality such as x-ray, fluoroscopy, computed tomography,electromagnetic radiation, ultrasound, visible light, UV light, magneticresonance imaging, positron emission tomography and neutron imaging. Theplurality of modifications may comprise an array of holes and/or notchesin the at least one surface of the radiopaque element. The array ofnotches in the at least one surface of the radiopaque element may format least one bar code. The at least one bar code may comprise a Hammingor similar type of code.

The elongate implant may be any implant amenable to the inclusion of anencoded, longitudinally extending radiopaque insert (i.e., relativelyradiopaque with respect to that of the implant material) and may includepedicle screws, surgical rods, pins, stents and the like. In oneembodiment, the elongate implant (such as a pedicle screw) may becannulated and the structurally encoded pin likewise cannulated so thatthe elongate implant may accept the encoded pin and also be amenable foruse in a minimal invasive surgical (MIS) operation. Accordingly, thestructurally encoded pin contained therein may itself be cannulated soas to be able, when disposed within the elongate implant and alignedalong the desired cannula axis, accept a guide wire. As such, theresultant cannulated elongate implant presents a channel through boththe structurally encoded pin and the elongate implant so as to be ableto be borne on an insertion wire used in such procedures. The presentinvention thus includes an embodiment wherein the implant body comprisesan implant body longitudinal cannula extending through the implant body.Additionally, the structurally encoded pin may be contained within theimplant body longitudinal cannula, with the structurally encoded pinitself comprising a pin longitudinal cannula, with the implant bodylongitudinal cannula and pin longitudinal cannula being aligned so as tocreate a wire-accepting cannula there through.

Alternatively, the present invention may include an elongate implantcomprising: an implant body defining a longitudinal axis; and astructurally encoded pin contained within the implant body and alignedsubstantially along the longitudinal axis, the structurally encoded pincomprising a shape or a surface characteristics discernable by animaging modality such as, but not limited to, x-ray, fluoroscopy,computed tomography, electromagnetic radiation, ultrasound, visiblelight, UV light, magnetic resonance imaging, positron emissiontomography and neutron imaging, from outside the screw body, the shapeor surface characteristics representing structurally encoded data. Theshape or surface characteristics may be placed in the structurallyencoded pin through electronic discharge manufacturing or throughadditive manufacture.

The elongate implant may serve as any bodily implant or part thereof,such as articles selected from the group consisting of pedicle screws,rods and surgical pins. In some implants the implant body comprises animplant body longitudinal cannula extending through the implant body,and may be such that the structurally encoded pin is contained withinthe implant body longitudinal cannula. The structurally encoded pincomprises a pin longitudinal cannula, and the implant body longitudinalcannula and the pin longitudinal cannula are aligned with one another.

The present invention also includes a method of producing an elongateimplant containing a structurally encoded pin and comprising: preparinga readable encoded relatively radio-opaque insert portion of theimplant, the insert portion encoded with data relating to the implantand encoded into the insert portion through an electronic dischargemanufacturing or additive manufacturing process; and encasing orinserting the insert portion into the elongate implant so as to containthe insert portion therein.

Additionally, the implant body may be manufactured so that there is animplant body longitudinal cannula extending through the implant body,and wherein the structurally encoded pin is contained within the implantbody longitudinal cannula, and further wherein the structurally encodedpin is formed to include a pin longitudinal cannula, the implant bodylongitudinal cannula and the pin longitudinal cannula being aligned onceencased or inserted into the elongate implant.

The present invention may also include an array of elongate implants(such as functional screws, pins, rods, stents and the like) bearing anencoded, longitudinally-extending radiopaque insert, the array beingdisposed in a non-eclipsed array with respect to a source of readingillumination of any imaging modality.

Another aspect of the present invention is a carrier containment systemadapted to contain a plurality of elongate implants (such as functionalscrews, pins, rods, stents and the like) bearing an encoded,longitudinally-extending radiopaque insert, and to maintain theplurality of functional implants in an array, the array being disposedin a non-eclipsed disposition with respect to the source ofillumination, and amenable to sterilization. The carrier may be made ofany appropriately radio-translucent material to permit imaging of theencoded inserts, and to permit sterilization where desired, such asplastic materials.

Yet another aspect of the present invention is a method of reading, froma single vector, data from a plurality of elongate implants (such asfunctional screws, pins, stents and the like) bearing an encoded,longitudinally-extending radiopaque insert, and arranged in an array,the array being disposed such that the inserts are maintained in anon-eclipsed disposition with respect to the source of illumination. Themethod also includes steps of decoding the data, storing the data forretrieval, and/or displaying information associated with the implantbased on the indicia and the plurality of records through a userinterface, in accordance with known data processing and computerdisplays currently being used in the art.

In accordance with further aspects of the present invention, a method ofmanufacturing an elongate implant bearing the relatively radio-opaqueinsert is provided. This method comprises generally preparing a readableencoded relatively radio-opaque insert portion of the implant, andinserting or otherwise manufacturing, through a co-injection molding,additive manufacturing or other suitable manufacturing process, a mainportion of the implant device so as to contain the readable insertportion of the implant. This may be done by 3D printing a firstrelatively radio-opaque material so as to structurally encode thepredetermined data into the readable insert portion surface, and further3D printing the second implant body material onto the first readableinsert portion to enclose it within the implant body material. This alsomay be done by equivalent molding methods effective to enclose thereadable insert portion within the implant body material. As analternative, the implant body material may be manufactured first,followed by drilling a channel into which the readable insert portionmay be inserted and the channel closed thereafter in a secondary moldingor additive manufacture operation.

The material from which the relatively radio-opaque insert may beproduced, especially through additive manufacture, may be selected fromthe group consisting of relatively radio-opaque polymers, ceramics,rubbers, metals, alloys or mixture thereof, using the additivemanufacture processes and devices known and used in the art to createsuch objects. Other materials may include relatively radio-opaquehydrogels, fluids, biologic materials, and the like that may be adaptedto be structurally encoded so as to maintain a shape encoding data asdescribed herein.

Another aspect of the present invention comprises a method machining ofnotches in implants such as pins through electrical discharge machining(EDM) processes to produce arrays of wires or sinkers. These arrays maythen be linked to software controlling the encoded patterns representingdata such as sequential serial numbers so parts could automatically bemade without operator interaction. EDM applicable to the invention mayuse create a desired shape by using electrical discharges to removematerial from the workpiece by a series of rapidly recurring currentdischarges between two electrodes, separated by a dielectric liquid andsubject to an electric voltage. This method thus affords a relativelyinexpensive and efficient process by way of which encoded data may beembodied in the elongate implant.

The present invention further comprises a reading system for reading aplurality of elongate implants each containing a structurally encodedpin, comprising: a carrier having a front surface defining a front axisand an upper surface, the upper surface having a plurality of aperturesarrayed in one or more series at an angle to the front axis, such thatall the elongate implants extending through each of the apertures in theseries may be read by a source of reading illumination directed along avector approximately orthogonal to the front axis; a plurality ofelongate implants extending through each of the apertures in the series,each elongate implant defining a longitudinal axis, and having astructurally encoded pin contained within the elongate implant andaligned substantially along the longitudinal axis, the structurallyencoded pin having a shape or surface characteristics discernable by thesource of reading illumination from outside the elongate implant, theshape or surface characteristics representing structurally encoded data;and a source of reading illumination directed at the plurality ofelongate implants along the vector orthogonal to the front axis.

The source of reading illumination may be selected from the groupconsisting of x-ray, fluoroscopy, computed tomography, electromagneticradiation, ultrasound, visible light, UV light, magnetic resonanceimaging, positron emission tomography and neutron imaging.

The reading system may also optionally include means of moving thesource of reading illumination with respect to the carrier along thefront axis. This means may include any means such as manual movement orthrough the use of mechanical or electromechanical arrangements adaptedto move the reading illumination with respect to the carrier along thefront axis, such as along the axes described in the drawings.

Also included in the present invention is a method of reading aplurality of elongate implants each containing a structurally encodedpin, comprising: providing a carrier having a front surface defining afront axis and an upper surface, the upper surface having a plurality ofapertures arrayed in one or more series at an angle to the front axis,such that all the elongate implants extending through each of theapertures in the series may be read by a source of reading illuminationdirected along a vector orthogonal to the front axis; the carriercontaining a plurality of elongate implants extending through each ofthe apertures in the series, each elongate implant defining alongitudinal axis, and having a structurally encoded pin containedwithin the elongate implant and aligned substantially along thelongitudinal axis, the structurally encoded pin having a shape orsurface characteristics discernable by the source of readingillumination from outside the elongate implant, the shape or surfacecharacteristics representing structurally encoded data; and positioningthe source of reading illumination directed at the plurality of elongateimplants along the vector orthogonal to the front axis, so as to readthe structurally encoded data from each of the elongate implants. Thismethod may additionally comprise the step of decoding the structurallyencoded data through microprocessor driven algorithms, and/or storingthe structurally encoded data using computer and electronic storagemedia, and the like.

The present invention further comprises a reading system for reading aplurality of implants (such as those of shapes other than those thatlend themselves to being held by a carrier of the type described forelongate implants), each containing a relatively radiopaque encodedportion. This system comprises: a carrier having a front surfacedefining a front axis and an upper surface, the upper surface comprisinga plurality of wells arrayed in one or more series at an angle to thefront axis, such that all the radiopaque encoded portions, when theimplants are contained within the wells may be read by a source ofreading illumination directed along a vector orthogonal to the frontaxis; a plurality of implants each containing a relatively radiopaqueencoded portion and contained within the wells in the one or moreseries, each the radiopaque encoded portion having a shape or surfacecharacteristics discernable by the source of reading illumination fromoutside the implant, the shape or a plurality of surface characteristicsrepresenting structurally encoded data; and a source of readingillumination directed at the plurality of implants along the vectororthogonal to the front axis.

The source of reading illumination and means of moving the source ofreading illumination with respect to the carrier along the front axismay be as described supra.

Also included in the present invention is a method of reading aplurality of implants each containing a relatively radiopaque encodedportion, comprising: providing a carrier having a front surface defininga front axis and an upper surface, the upper surface having a pluralityof wells arrayed in one or more series at an angle to the front axis,such that all the radiopaque encoded portions, when the implants arecontained within the wells may be read by a source of readingillumination directed along a vector orthogonal to the front axis thecarrier containing a plurality of implants each containing a relativelyradiopaque encoded portion and contained within the wells in the one ormore series, each the radiopaque encoded portion having a shape orsurface characteristics discernable by the source of readingillumination from outside the implant, the shape or surfacecharacteristics representing structurally encoded data; and directing anexternal source of reading illumination at the plurality of elongateimplants along the vector orthogonal to the front axis, so as to readthe structurally encoded data from each of the elongate implants. Thismethod may further comprise the additional steps of decoding thestructurally encoded data through microprocessor driven algorithms,and/or storing the structurally encoded data using computer andelectronic storage media, and the like.

Accordingly, the implants of the present invention may have encodedtherein some information through the use of the structurally encodedpins of the present invention, while other information may be encodedthrough use of the encoded inclusion patterns described in thereferenced application. Likewise, by combining aspects of the inventionone can use the methods together for similar information (either forredundancy or using different methods for reading the information),different information, or some combination of the same or differentinformation, as well as further through the use of embedded chips, etc.for other information within such an encoding scheme.

It will be appreciated that the present invention may be applied toother fields for the inventory management of articles in any industry,such as in the case of articles that may include parts used inmanufacturing, such as in the case of automobiles and parts therefor,firearms and parts therefor or jewelry and parts therefor.

In the use of elongate implants it is also beneficial to provide meansfor organizing, reading, inventorying and using such implants in atherapeutic application, such as in surgical settings and the like.

The container of the present invention may be used along with a sourceof reading illumination, such as x-rays and the like, so as to permitall of the encode inserts in respective articles to be viewed (anddecoded) to permit inventory to be tracked and managed in the samemanner as the subject implants may be tracked and managed both beforeand after introduction into the body. The present invention may beapplied to other industries, allowing the operator to track anything inany industry with an encoded insert or pin and a source of readingillumination, such as x-rays or the like.

To the accomplishment of the forgoing and related ends, certainillustrative aspects are described herein in connection with thefollowing description and the annexed drawings. These aspects areindicative of the various ways in which the principles disclosed hereincan be practiced and all aspects and equivalents thereof are intended tobe within the scope of the claimed subject matter. Other advantages andnovel features will become apparent from the detailed description whenconsidered in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the present invention, it is believed that thepresent invention will be better understood from the followingdescription in conjunction with the accompanying Figures, in which likereference numerals identify like elements, and wherein:

FIG. 1 illustrates an in situ view of an x-ray image of an elongateimplant in accordance with the disclosed architecture.

FIG. 2 illustrates a top plan view of a carrier for retaining aplurality of elongate implants in accordance with the disclosedarchitecture.

FIG. 3 illustrates a front perspective view of the carrier in accordancewith the disclosed architecture.

FIG. 4 illustrates a top plan view of the carrier bearing the pluralityof elongate implants in accordance with the disclosed architecture.

FIG. 5 illustrates a front perspective view of the carrier bearing theplurality of elongate implants in accordance with the disclosedarchitecture.

FIG. 6 illustrates an upper perspective view of a container bearingthree carriers in turn each carrier bearing some of the plurality ofelongate implants in accordance with the disclosed architecture.

FIG. 7A illustrates a mock x-ray image of an elevation view of thecarrier bearing the plurality of elongate implants in accordance withthe disclosed architecture.

FIG. 7B illustrates a mock x-ray image of an elevation view of thecontainer bearing three carriers in turn each carrier bearing some ofthe plurality of elongate implants in accordance with the disclosedarchitecture.

FIG. 8 illustrates a top plan view of an empty interbody cage carrier inaccordance with the disclosed architecture.

FIG. 9 illustrates a top perspective view of the empty interbody cagecarrier in accordance with the disclosed architecture.

FIG. 10 illustrates a front perspective view of an implant carrier inaccordance with the disclosed architecture.

FIG. 11 illustrates an elevation view of a series of implant racks asthey would appear when arrayed within the implant carrier in accordancewith the disclosed architecture.

FIG. 12 illustrates a top perspective view of an implant carrier bearinga plurality of encoded implants in accordance with the disclosedarchitecture.

FIG. 13 illustrates a detailed partially sectioned top perspective viewof the implant carrier bearing the plurality of encoded implants inaccordance with the disclosed architecture.

FIG. 14 illustrates a further detailed partially sectioned topperspective view of the implant carrier bearing the plurality of encodedimplants in accordance with the disclosed architecture.

FIG. 15 illustrates a lateral view of an encoded implant in accordancewith the disclosed architecture.

DETAILED DESCRIPTION

In the following detailed description of the preferred embodiment,reference is made to the accompanying drawings that form a part hereof,and in which is shown by way of illustration, and not by way oflimitation, a specific preferred embodiment in which the invention maybe practiced. It is to be understood that other embodiments may beutilized and that changes may be made without departing from the spiritand scope of the present invention.

The invention generally relates to an elongate implant comprising animplant body defining a longitudinal axis; and a structurally encodedpin contained within the implant body and aligned substantially alongthe longitudinal axis, the structurally encoded pin comprising a shapeor a plurality of surface characteristics representing structurallyencoded data which may be discerned from outside the implant body via avariety of imaging modalities, a carrier for the same, and systems andmethods of using both.

FIG. 1 illustrates an in situ view of an x-ray image of an elongateimplant 1, such as, but not limited to a relatively radio-translucentpedicle screw visible via an imaging modality 10, such as an x-ray. Theelongate implant 1 comprises an implant body (represented by the screwbody) having a longitudinal axis and a structurally encoded pin 2. Thestructurally encoded pin 2 is relatively radio-opaque and can be clearlyseen and generally appears as greyish-black in color in an x-ray asillustrated. The elongate implant 1 may comprise a plurality of malethreads 3 which can also be seen as greyish in color and relatively lessopacity on an x-ray.

The elongate implant 1 (such as a pedicle screw, rod or surgical pin)may be cannulated and comprise a longitudinal cannula 1A, such as achannel within the implant body, with the structurally encoded pin 2astride the longitudinal cannula 1A. The structurally encoded pin 2(i.e., radio-opaque encoded pin) likewise may comprise a longitudinalcannula 2A aligned the longitudinal channel 1A of the elongate implant 1so that the elongate implant 1 may accept the structurally encoded pin 2within and also be amenable for use in a minimal invasive surgical (MIS)operation. Accordingly, the structurally encoded pin 2 contained thereinmay itself be cannulated so that, when disposed or contained within theelongate implant 1 and aligned along the desired cannula axis, theresultant cannulated elongate implant 1 presents a channel (1A and 2Acollectively) through both the structurally encoded pin 2 and theelongate implant 1 so that the elongate implant 1 may be borne on aninsertion wire used in such procedures.

This encoder-pin variant of the present invention not only works for theelongate implant 1 comprising a single pedicle screw, but also works ona group of devices such as a plurality of pedicle screws resting insidea caddy/tray. The advantage is that a health care provider may image anentire set of implants or interbody devices, and decode the structurallyencoded information for full implant and instrument traceability. Inorder to do this, the carrier or caddy should feature holes orientatedsuch as those shown in FIGS. 2 and 3 based on the size and geometry ofthe pedicle screws, such that when x-ray or other reading radiation isemitted from the side direction, the implants or interbody devices, suchas pedicle screws, will not overlap with each other and result ineclipsed or otherwise unclear images.

The structurally encoded pin 2 used with the elongate implant 1, or anyinterbody device as described infra, comprises a shape or a plurality ofsurface characteristics to represent structurally encoded data. Whilethe shape is illustrated in FIGS. 1 and 4 as a rod or pin shape, as adisc shape in FIGS. 10 and 11, and geometrically shaped in FIGS. 12-14,the implant may comprise any shape desirable for an implantable device.One example of the plurality of surface characteristics may be thenotches illustrated in FIG. 15 as described infra.

FIG. 2 illustrates a top plan view of a carrier 4, such as, but notlimited to, a pedicle screw carrier in accordance with further aspectsof the present invention. The carrier 4 may comprise a plurality ofhandles 5 and a plurality of holding apertures 6 located in an uppersurface of the carrier 4 that are sized so as to be able to accept aseries of elongate implants 1 as shown in more detail in FIGS. 4 and 5.

FIG. 3 is a front perspective view of the carrier 4 empty of anyelongate implants 1. The carrier 4 comprises a front surface 7 and aside surface 8. The plurality of holding apertures 6 are preferablyarrayed in one or more series at an angle to the front 7 or side surface8, such as arrayed along axis A at an acute angle alpha with respect tofront surface 7, so as to allow the carrier 4 to be placed against analignment surface or device (not shown), so as to permit the user toscan the population of contained elongate implants 1 with the source ofreading illumination 10. The source of reading illumination 10 may bemoved along or reciprocated along direction B, such that the pluralityof structurally encoded pins 2 may be conveniently read without some ofthe pins eclipsing and thus obscuring other pins in the array. Theimaging modality 10 may comprise x-ray, fluoroscopy, computedtomography, electromagnetic radiation, ultrasound, visible light, UVlight, magnetic resonance imaging, positron emission tomography andneutron imaging, and the like.

The alignment surface or device may be in the form of an interiorsurface of container 11 shown in FIG. 6, or that of a tray or even asurface associated with the illumination device itself, to providealignment, typically orthogonal alignment, to the reading illuminationdirection.

FIG. 4 is a top plan view of the carrier 4 bearing the plurality ofelongate implants 1 extending through the plurality of holding apertures6 so as to extend below the aperture-containing top surface of thecarrier 4 and generally into free space within the carrier interior topermit the threaded portion 3 of each elongate implant 1 to besubstantially unobscured by any portion of the carrier 4 when read froma direction substantially orthogonal to the front surface 7, as may beappreciated from FIG. 5. FIG. 4 also shows the position of thelongitudinal cannula 1A in each of the elongate implants 1 as anoptional feature shown and described in FIG. 1. When disposed within theelongate implant 1 and aligned along the desired longitudinal cannulaaxis, the longitudinal cannula 1A of the elongate implant 1 and thelongitudinal cannula 2A within the structurally encoded pin 2 create achannel (1A and 2A collectively) through both the structurally encodedpin 2 and the elongate implant 1 so as to be able to be borne on aninsertion wire used in such procedures.

It will also be appreciated from FIG. 5 that an array of the holdingapertures 6 will also be dependent upon the size and geometry of theelongate implants 1, such that when X-ray is emitted from source 10, theelongate implants 1 will not eclipse one another with respect to thefront axis, resulting in unclear images and potential attendantmisreading of the encoded structure of the structurally encoded pins 2.The source of reading illumination 10 may also be used to take a singleimage, such as an x-ray, wherein all of the structurally encoded datapositioned within the carrier 4 is visible on the single image.Additionally, the carrier 4 may further comprise data related to theplurality of elongate implants 1. This data may be encodable onto orwithin the carrier 4 by any means that would be visible by the source ofreading illumination 10.

FIG. 6 shows a container 11 that may be used for storage or as animaging caddy for the implants or interbody devices of the presentinvention. As such, the carrier 4 or a plurality of carriers isretainable by within the container 11. FIG. 6 shows the elongateimplants 1, such as pedicle screws, placed and resting within aplurality of the carriers 4 (as seen more clearly in FIGS. 4 and 5).Three carriers 4 are shown as are placed inside one container 11.

The elongate implants 1 or interbody devices can be stored andsterilized in several ways in which the structurally encoded pins 2 maybe viewed from X-ray images thereof. FIG. 6 illustrates an upperperspective view of the container 11 bearing three carriers 4, as shownin FIGS. 4 and 5. The container 11 aligns the respective front (open)sides (i.e., the front surface 7 of each carrier 4) and may in turn beused to align those exposed sides, and the elongate implants 1 theyexpose, with respect to the reading illumination source 10, such as byhaving a longitudinal side 12 of the container 11 juxtaposed against abearing surface (not shown) that aligns the container 11 approximatelyorthogonally with respect to the reading illumination source 10.

FIG. 7A illustrates a mock x-ray image of an elevation view of thecarrier 4 representing a single surgical pedicle screw carrier bearingthe plurality of pedicle screws 1, and FIG. 7B illustrates a mock x-rayimage of an elevational view of three carriers 4 each bearing pediclescrews within a container (not shown) that is not visible via an x-ray,and showing the respective position of the contained radio-opaquestructurally encoded pins 2 in accordance with further aspects of thepresent invention. FIGS. 7A and 7B show the structurally encoded pins 2clearly and unobstructed visible along with the caddy descriptionunderneath. The caddy description represented by the word DESCRIPTION onthe side of the front surface 7 may be readable both with and withoutx-ray for further clarification to the user. The structurally encodedpins 2 are clearly visible along with the caddy description beneath themin the depicted embodiment. The advantage is that a health care providermay image an entire set and decode for full implant and instrumenttraceability.

FIG. 8 is a top plan view of an empty interbody cage carrier 13 inaccordance with another embodiment of the present invention. Theinterbody cage carrier 13 is shown without handles though they may beprovided as in the carrier 4 if desired. The interbody cage carrier 13comprises a plurality of holding apertures 14 that are sized so as to beable to accept a series of interbody cages or carriers 4 similar to themanner as shown in FIGS. 4 and 5. The plurality of holding apertures 14are preferably arrayed in one or more series at an angle to a frontsurface 15 or a side surface 16 (such as arrayed along axis C or D atacute angles beta or gamma respectively with respect to the frontsurface 15) so as to allow the interbody cage carrier 13 to be placedagainst an alignment surface or device so as to permit the user to scanthe population of contained interbody cages or carriers 4 with aplurality of sources of reading illumination 17 and 18 that may be movedalong or reciprocated along direct E. Thus, any radio-opaque encodedpins, such as the structurally encoded pins 2 of the plurality ofelongate implants 1 (not shown), may be conveniently read without someof the pins eclipsing and thus obscuring other pins in the array. Theplurality of sources of reading illumination 17 and 18 comprise imagingmodalities such as x-ray, fluoroscopy, computed tomography,electromagnetic radiation, ultrasound, visible light, UV light, magneticresonance imaging, positron emission tomography and neutron imaging, andthe like as described supra.

FIG. 9 illustrates a top perspective view of the empty interbody cagecarrier 13. In this illustration, the carriers 4 or interbody cages maybe inserted into the interbody cage carrier 13 so as to extend alongline H below a bottom of the interbody cage carrier 13 and into anintended path of the sources of reading illumination 17 and 18. Theinterbody cage carrier 13 may be used in conjunction with an additionaltray or similar container having a top edge that is sized to engage theinterbody cage carrier 13 so as to permit the interbody cages to besecured in an enclosed space to maintain sterility. FIGS. 8 and 9 thusshow unloaded versions of the interbody cage carrier 13 further depictedand described in FIGS. 13 and 14.

FIG. 10 illustrates a front perspective view of another variant of theinvention as may be used for the carriers 4, interbody cages, and thelike. FIG. 10 illustrates an implant carrier 20 comprising a frontsurface 21 and a side surface 22. The implant carrier 20 furthercomprises a plurality of apertures 23 in a bottom surface 24 forpositioning a plurality of implant racks 25A-C. The plurality ofapertures 23 are arrayed in one or more series at an angle to the frontsurface 21 or the side surface 22 (such as arrayed along axes F or G atacute angles delta or epsilon, respectively, with respect to frontsurface 21) so as to allow the implant carrier 20 to be placed againstan alignment surface or device so as to permit the user to scan apopulation of contained implants 26 hanging on the plurality of implantracks 25A-C with a source of reading illumination 27 (i.e., discernableby an imaging modality such as x-ray, fluoroscopy, computed tomography,electromagnetic radiation, ultrasound, visible light, UV light, magneticresonance imaging, positron emission tomography and neutron imaging,etc.) that may be moved along or reciprocated along direction E. In thisway, all of the plurality of implants 26 hanging on the plurality ofimplant racks 25Aa, 25B and/or 25C (which may be of different shapeand/or with different number of extension arms or various sizes asexemplified by the implant racks 25A, 25B and/or 25C) may beconveniently read without some of the plurality of implants 26 eclipsingand thus obscuring other implants 26 in the array.

The alignment surface or device may be in the form of the interiorsurface of container 11 shown in FIG. 6 or the like, or that of a trayadapted to fit against the front surface 21 and the side surface 22, oreven a surface associated with the illumination device itself, toprovide alignment, typically approximately orthogonal alignment, to thereading illumination direction.

In this embodiment, the plurality of implants 26 may be of any shapeamenable to being hung upon, distended over or otherwise captured by theimplant racks 25A, 25B and/or 25C, such as ring-shaped as is the case ofthe plurality of implants 26.

It will appreciated that the plurality of implant racks 25A, 25B and/or25C may be releasably maintained in the respective aperture 23 such asby a set screw or the like (not shown) to allow the plurality of implantracks 25 to be repositioned anywhere along the extend of the givenaperture 23 and also turned within the given aperture 23 to allow thegiven implant rack 25A-C to have its hanging arms positionedbeneficially with respect to the source of reading illumination 27, toallow, for instance, multiple implant racks such as the implant racks25A-C, to be positioned and affixed to permit the implants supportedthereupon to present a readable attitude to the source of readingillumination 27 in a spatially efficient fashion. For this reason,several series of apertures 23 may be used to accommodate any givennumber, size and shape of implant.

FIG. 11 is an elevation view of the series of implant racks 25A, 25B and25C as they would appear when arrayed within the implant carrier 20.Interbody devices such as the plurality of implants 26 can be placed inthe caddy or hung from the caddy bars (depending upon their geometry,such as curved, having angled sections or otherwise amenable to havingtheir center of gravity supported by implant racks 25A, 25B and/or 25C)to have a clear view of the structurally encoded pins 2 from lateralX-ray images.

The plurality of implants 26 may be generally circular hollow implantssuited to be hung upon implant racks 25 a, 25 b and/or 25 c as shown inFIG. 10, such as those described in U.S. Provisional Application No.62/204,233, filed Aug. 12, 2015, and U.S. patent application Ser. No.15/235,914 filed Aug. 12, 2016 (both of which are incorporated herein byreference in their entirety) having a plurality of encoded readableelements, such as one or more orientation marker rods. The plurality ofimplants 26 may be manufactured using the same general method steps asdescribed herein, such as by co-injection molding or additivemanufacturing processes.

FIG. 12 illustrates a top perspective view of an implant carrier 27bearing a plurality of encoded implants 28, 29 and 30 in accordance withanother embodiment of the present invention. The implant carrier 27holds the plurality of implants 28, 29 and 30 in a plurality ofindividual wells 32 such that a source of reading illumination 31 (i.e.,discernable by an imaging modality such as x-ray, fluoroscopy, computedtomography, electromagnetic radiation, ultrasound, visible light, UVlight, magnetic resonance imaging, positron emission tomography andneutron imaging, etc.) may be moved along or reciprocated alongdirection L. In this way, the plurality of implants 28, 29, 30 aremaintained in a non-eclipsing series, such as along axes I, J, and K,each of which in turn contain four structurally encoded pins 2 similarto those described with respect to the elongate implants 1, and may beconveniently read without other of the implants eclipsing and thusobscuring other implants in the array.

FIG. 13 illustrates a detailed view of FIG. 12, partially sectionedalong line A-A showing a top perspective view of the implant carrier 27bearing a plurality of encoded implants 32, 33, 34 and 35 in a pluralityof individual wells 32A, 33A, 34 A and 35A, respectively. FIG. 13 alsoshows a plurality of apertures 36 that may be used to suspend theplurality of elongate implants 1 as described in the earlier FIGS. FIG.13 further shows that the plurality of apertures 36 may be used tosuspend a plurality of the pedicle screws as described supra.

FIG. 14 illustrates a detailed view of FIG. 12, partially sectionedalong line A-A A showing a top perspective view of the implant carrier27 bearing the plurality of encoded implants 32 and 33 in the pluralityof individual wells 32A and 33A, respectively. FIG. 14 also shows anencoded pin 32B which may become aligned in a non-eclipsed fashion bythe placement of the plurality of encoded implants 32 and 33 in theplurality of individual wells 32A and 33A.

FIG. 15 illustrates a lateral elevation view of a series of theradio-opaque encoded pin 2. The radio-opaque encoded pin 2 may comprisea plurality of notches 37 placed in the encoded pin 2 through electricaldischarge machining (EDM) processes to produce arrays of wires orsinkers encoded with data. The plurality of notches 37 is exemplary ofthe plurality of surface characteristics representing the structurallyencoded data.

The information or data encoded onto or into the implant devices of theembodiments disclosed in the present invention may be detected, decoded,read, transferred, stored, displayed, or processed according to suchmethods and devices disclosed in U.S. Pat. No. 8,233,967 or U.S. PatentApplication Publication No. 2013/0053680, both of which are incorporatedherein by reference.

The implantable devices such as the elongate implant 1 comprising theimplant body defining the longitudinal axis or the circular implants 26may be manufactured using additive manufacturing (AM) techniques, orusing a combination of other molding or machining techniques (injectionmolding, machining, etc.) to produce the subject encoded implants. Theseadditional techniques include without limitation material extrusion, vatphoto polymerization, powder bed fusion, material jetting, binderjetting, sheet lamination and directed energy deposition.

The implantable devices used in accordance with the present inventionmay be manufactured by conventional methods such as a machiningoperation using any milling, lathe, or drilling operation to includestandard machining and fabrication methods known in the art ofmanufacturing medical implants.

The present invention allows for the convenient, accurate and efficientreading of structurally encoded articles, which refers to the 3Dencoding of digital information in a structure as variations ingeometric or physical features—widths, densities, color, feature angles,etc. Bar codes are an example of a 2D encoding of digital informationwith modulations of color (dark versus light) with varying widths ofprinted bars on a surface. A typical embodiment of the structurallyencoded devices of the present invention may contain data that is notreadily apparent to a viewer of the device structure. Further, encodingof the typical embodiments of the present invention is handled byphysical means other than those accomplished through circuitry,electromagnetic or other means, within the implant device itself orthrough a type of internal storage means such as magnetic storage meansor the like. Such structurally encoded devices, as disclosed herein anddescribed in relation to the typical and/or preferred embodiments of thepresent invention allow simplified production, maintenance, and/oroperation costs for identification, storage, and/or retrieval of uniqueimplant data while retaining a substantial amount of information withreduced probability for error.

The implant device carrier of the present invention enables betterreporting, reviewing, inventorying and analyzing of implant devices toreduce medical error by enabling health care professionals and others torapidly and precisely identify an implant device and obtain importantinformation concerning the characteristics of the device, principallyprior to installation. The present invention enhances analysis ofdevices on the market by providing a standard and clear way to documentdevice use in electronic health records, clinical information systems,claim data sources, and registries.

It will also be appreciated that the present invention may be applied tosimilarly prepared articles such as articles that may benefit fromstructurally encoded structures as in the present invention. Sucharticles may include parts used in manufacturing, such as in the case ofautomobiles and parts therefor, firearms and parts therefor or jewelryand parts therefor.

The present invention also includes methods of reading the structurallyencoded articles, as well as an inventory management system forstructurally encoded articles that includes reading the encoded datafrom the encoded articles and storing the acquired data.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, a certain illustrated embodiment thereof isshown in the drawings and has been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

Preferred embodiments of this invention are described herein. Variationsof those preferred embodiments may become apparent to those of ordinaryskill in the art upon reading the foregoing description. The inventorexpects skilled artisans to employ such variations as appropriate, andthe inventor intends for the invention to be practiced otherwise than asspecifically described herein. Accordingly, this invention includes allmodifications and equivalents of the subject matter recited in theclaims appended hereto as permitted by applicable law. Moreover, anycombination of the above-described elements in all possible variationsthereof is encompassed by the invention unless otherwise indicatedherein or otherwise clearly contradicted by context.

What is claimed is:
 1. A system for reading a plurality of elongateimplants comprising: the plurality of elongate implants; a carriercomprising a front surface defining a front axis and an upper surface,said upper surface comprising a plurality of apertures arrayed in one ormore series and wherein the plurality of elongate implants extendthrough said plurality of apertures in said series; and a source ofreading illumination located external to and directable at saidplurality of elongate implants along a vector orthogonal to said frontaxis, wherein said source of reading illumination reads all of saidplurality of elongate implants retained within said carrier in a singleimage.
 2. The system of claim 1, wherein each elongate implant comprisesa structurally encoded pin comprising a shape or a plurality of surfacecharacteristics representing structurally encoded data that arediscernable by said source of reading illumination, and wherein all ofsaid structurally encoded data retained within said carrier isdiscernable in a single image from said source or reading illumination.3. The system of claim 1, wherein said source of reading illumination isselected from the group consisting of x-ray, fluoroscopy, computedtomography, electromagnetic radiation, ultrasound, visible light, UVlight, magnetic resonance imaging, positron emission tomography andneutron imaging.
 4. The system of claim 1, wherein the source of readingillumination is movable along said front axis.
 5. A method of reading aplurality of elongate implants comprising: providing a carriercomprising a front surface defining a front axis and an upper surface,said upper surface comprising a plurality of apertures arrayed in one ormore series, and a plurality of elongate implants having a structurallyencoded data thereon extending through said plurality of apertures insaid series; directing an external source of reading illumination atsaid plurality of elongate implants along a vector substantiallyorthogonal to said front axis; and using said external source of readingillumination to capture all of said structurally encoded data in asingle image.
 6. The method of claim 5, further comprising the step ofencoding the carrier with data related to said plurality of elongateimplants.
 7. The method of claim 5 further comprising the step ofdecoding said structurally encoded data.
 8. The method of claim 5further comprising the step of storing said structurally encoded data.9. A system for reading a plurality of implants comprising: theplurality of implants; a carrier comprising a front surface defining afront axis and an upper surface, said upper surface comprising aplurality of wells arrayed in one or more series at an angle to saidfront axis; and wherein the plurality of implants each comprise arelatively radiopaque encoded portion and are each contained within saidwells in said one or more series, each said radiopaque encoded portioncomprising a shape or a plurality of surface characteristicsrepresenting structurally encoded data; and an external source ofreading illumination for reading the structurally encoded datadirectable at said plurality of implants along a vector orthogonal tosaid front axis, wherein the external source of reading illuminationcaptures all of said structurally encoded data in a single image. 10.The system of claim 9, wherein said external source of readingillumination is selected from the group consisting of x-ray,fluoroscopy, computed tomography, electromagnetic radiation, ultrasound,visible light, UV light, magnetic resonance imaging, positron emissiontomography and neutron imaging.
 11. The system of claim 9, wherein theexternal source of reading illumination with respect to said carrier ismovable along said front axis.
 12. A method of reading a plurality ofimplants comprising: providing a carrier comprising a front surfacedefining a front axis and an upper surface, said upper surfacecomprising a plurality of wells arrayed in one or more series at anangle to said front axis, said carrier containing a plurality ofimplants each comprising a relatively radiopaque encoded portioncontained within said wells in said one or more series, each radiopaqueencoded portion comprising a shape or a plurality of surfacecharacteristics representing structurally encoded data; and directing anexternal source of reading illumination at said plurality of implantsalong a vector orthogonal to said front axis, so as to read saidstructurally encoded data from each of said plurality of implants; andusing said source or reading illumination to capture all of saidstructurally encoded data retained within said carrier in a singleimage.
 13. The method of claim 11, further comprising the steps ofdecoding and storing said structurally encoded data.